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Trump seeks to put COVID-19 behind him, get back to election campaign

By Andrea Shalal

WASHINGTON (Reuters) – Donald Trump is no longer a transmission risk for COVID-19, his doctor said late on Saturday, as the U.S. president seeks to put his bout with coronavirus behind him and return to the campaign fray.

Trump, trailing his Democratic challenger Joe Biden in opinion polls, addressed supporters from a White House balcony on Saturday afternoon. He urged a crowd of hundreds of largely Black and Latino supporters to help get out the vote in the Nov. 3 election.

His physician Sean Conley said in a statement later that Trump had taken a test on Saturday showing he was no longer “a transmission risk to others,” and there was no longer evidence “of actively replicating virus.”

The White House had no immediate comment on whether Conley’s statement meant Trump had actually tested negative for the coronavirus.

Trump first revealed that he had tested positive on Oct. 2, and spent three days in hospital. The White House has not disclosed when Trump last tested negative.

Trump is eager to get back on the campaign trail after an absence of more than a week. He plans to travel to the key battleground state of Florida on Monday, followed by rallies in Pennsylvania and Iowa on Tuesday and Wednesday, respectively.

“I’m feeling great,” he told the crowd.

The president’s illness has cast a spotlight on the pandemic, which has infected nearly 7.7 million people in the United States and killed over 213,000. His administration has faced criticism for its handling of the crisis, and for its lax approach to mask-wearing and social distancing in the White House. At least 11 close Trump aides have tested positive for coronavirus.

Speaking firmly and with no sign of the raspy throat evident in recent interviews, Trump delivered a shorter-than-usual campaign speech.

He attacked Democrats as pursuing a “socialist” or even “Communist” agenda, and hailed his own record in fighting crime and boosting the U.S. economy, while flag-waving supporters cheered and chanted, “We love you.”

Democrats and some commentators criticized Saturday’s event for potentially exposing a new batch of supporters to the virus and for using a federal building as an election prop.

Asked about it in New Castle, Delaware, Biden said he hoped the president and his supporters were taking precautions.

“They should be socially distant and wearing masks,” he said. “It’s the only responsible thing to do.”

Trump standing alone at the event, was not wearing a mask as he spoke. In the crowd, most were wearing masks but not following social distancing guidelines.

Trump repeated past calls for states to reopen their economies even as new cases hit a two-month high on Friday. A Reuters analysis showed more than 58,000 infections were reported and hospitalizations in the Midwest hit a record for a fifth successive day.

Opinion polls show Biden with a substantial lead nationally, although with a narrower advantage in some of the states that may decide the election outcome.

(Reporting by Andrea Shalal and Jason

Novel Brain Surgery Seeks to Reverse Epilepsy in Sea Lion

VALLEJO, Calif. — The adolescent patient turned sullen and withdrawn. He hadn’t eaten in 13 days. Treatment with steroids, phenobarbital and Valium failed to curb the symptoms of his epilepsy. Then, on Sept. 18, he had a terrible seizure — violently jerking his flippers and turning unconscious in the water.

Cronutt, a 7-year-old sea lion, had to be rescued so he didn’t drown. His veterinarian and the caretakers at Six Flags Discovery Kingdom began discussing whether it was time for palliative care.

“We’d tried everything,” said Dr. Claire Simeone, Cronutt’s longtime vet. “We needed more extreme measures.”

On Tuesday morning, Cronutt underwent groundbreaking brain surgery aimed at reversing the epilepsy.

If successful, the treatment could save increasing numbers of sea lions and sea otters from succumbing to a new plague of epilepsy. The cause is climate change.

As oceans warm, algae blooms have become more widespread, creating toxins that get ingested by sardines and anchovies, which in turn get ingested by sea lions, causing damage to the brain that results in epilepsy. Sea otters also face risk when they consume toxin-laden shellfish.

The animals who get stranded on land have been given supportive care, but often die. Cronutt may change that.

“If this works, it’s going to be big,” said Mariana Casalia, a neuroscientist at the University of California, San Francisco, who helped pioneer the techniques that led to a procedure that took place a vet surgery center in Redwood City, Ca.

That procedure was done by three neurosurgeons at U.C.S.F., who ordinarily operate on humans. During the operation, they bored a small hole in Cronutt’s skull, inserted an ultrathin needle into the hippocampus of the sea lion’s brain, then implanted embryonic brain cells extracted from a 35-day-old pig. These so-called “inhibitory cells” tamp down the electrical activity in the brain that leads to seizures, a process identified by Scott Baraban, a professor of neurosurgery who runs the lab where Dr. Casalia works. Over a decade, their technique has proved effective in curing epilepsy in mice.

Credit…Claire Simeone

Cronutt, the first higher mammal to get the treatment, emerged from the surgery and anesthesia midday and was breathing on his own, a first step. Whether the surgery successfully reverses his condition won’t be known for several weeks.

Pig cells are important because they have properties of higher mammal species, including the sea mammals succumbing to epilepsy. And sea lions and sea otters are increasingly at risk for the disease.

The widely documented phenomenon, first discovered in 1998, led to a surge in beaching of sea lions in 2002, another in 2015, and annual summer beachings. By now, thousands of sea lions have been poisoned by the toxin, called domoic acid. It depletes inhibitory cells that ordinarily help offset excitatory cells in the brain’s electrical system. When those cells get out of balance, seizures

Maker of Antibody Cocktail Trump Took Seeks Emergency Use OK | Health News

By Robin Foster and E.J. Mundell
HealthDay Reporters

(HealthDay)

THURSDAY, Oct. 8, 2020 (HealthDay News) — Regeneron Pharmaceuticals Inc. said Wednesday that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to President Donald Trump shortly after he was diagnosed with COVID-19.

Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an “unbelievable” effect on his recovery from coronavirus infection, the Washington Post reported.

“I think this was the key,” Trump said, after acknowledging that the antibody cocktail was one of several drugs he was prescribed by his medical team. While there is no hard evidence yet proving the drug’s effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.

In his video, Trump said, “I have emergency-use authorization all set, and we’ve got to get it signed now.” However, an FDA spokeswoman told The New York Times Wednesday that the agency does not confirm or deny product applications.

Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.

The antibody cocktail is now in late-stage testing. The company has granted fewer than 10 “compassionate use” requests allowing people not enrolled in its trials to use the drug, the Associated Press reported.

The U.S. government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported.

Regeneron isn’t the only company developing an antibody cocktail to battle COVID-19 infection: Eli Lilly and Co. announced earlier on Wednesday that it was seeking emergency-use authorization from the FDA for a similar cocktail. Both treatments use lab-made antibodies to give patients’ immune systems a boost. In both cases, scaling up production to meet demand is expected to be a major challenge, the Post reported.

White House approves tougher vaccine development rules

Following weeks of delay, the White House on Tuesday approved tough new rules for coronavirus vaccine developers that will make it unlikely that a vaccine will be approved before Election Day.

The approval came only after the U.S. Food and Drug Administration published the updated guidelines on its website as part of briefing materials for outside vaccine advisers, the Post reported.

The standards, which would be applied to an emergency-use authorization for a vaccine, are similar to the standards for a traditional approval. But the White House has worried that the criteria would delay authorization of a vaccine beyond Nov. 3 and sat on the guidance, the Post reported.

The delayed clearance by the White House came only after White House Chief of Staff Mark Meadows demanded detailed justification from the agency about the tougher criteria, the Post reported. The FDA provided the White House with additional data,

Eli Lilly Seeks FDA Approval On Coronavirus Treatment, Potentially Easing Rush For A Vaccine

KEY POINTS

  • Eli Lilly’s three trials over the summer yielded positive results in patients with mild- to moderate-cases of coronavirus
  • The company could have nearly 1 million doses ready for distribution by the end of 2020 with FDA approval
  • Temporary protections provided by the antibody treatment could potentially give pharmaceutical companies more time to develop stronger vaccines

Pharmaceutical company Eli Lilly & Co. asked the U.S. Food and Drug Administration Wednesday to authorize the use of a potential coronavirus treatment that’s shown promising results during clinical trials.

Eli Lilly asked the FDA to authorize the drug’s emergency use after results for their first three clinical trials all came back positive in people with mild- to moderate-cases of coronavirus. If approved, Eli Lilly said it could have 100,000 doses ready to go within a month and 1 million ready by the end of 2020.

However, it would not be used on more severe cases, since it has not proven to be as effective in treating those cases.

The drug, codenamed LY-CoV555, is in an antibody drug Eli Lilly has been developing with Canadian pharmaceutical company AbCellera Biologics Inc. AbCellera started by taking blood samples from one of the first coronavirus patients in the U.S. to recover when it began working with Eli Lilly. The two then started developing an antibody drug treatment based on the antibodies found in the patient’s blood sample.

Trials began in June, when hospitalized patients being treated for coronavirus were dosed randomly with either the drug or a placebo to measure the drugs effectiveness. After results showed the drug helps treat the virus, phase 2 trials were conducted among vulnerable populations who were randomly administered a placebo or one of two potential drugs, including alternate antibody treatment LY-CoV016.

The most recent trials were conducted in nursing homes and, as before, showed the drug helped treat the symptoms of coronavirus and could temporarily protect against it. The latter half of the results would be important because it could ease the pressure on other pharmaceutical companies to develop a full vaccine.

One company which would benefit from this, in that regard, is AstraZeneca Plc. U.S. trials for AstraZeneca’s potential vaccine have been on hold since September after one patient was diagnosed with unexpected neurological symptoms after being inoculated. Trials have continued overseas.

That said, AstraZeneca may still rush to get a vaccine out as its pledge not to profit from it runs through July 2021. Under its current contractual agreement, Astrazeneca could declare the pandemic over by then and begin profiting off its distribution. The period could be extended if AstraZeneca acts “in good faith” if the pandemic is not considered over.

The company said it expects to receive an update about possibly resuming its U.S. trials in the next two weeks.

Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company's experimental Covid-19 vaccine Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company’s experimental Covid-19 vaccine Photo: AFP / ANDREW CABALLERO-REYNOLDS

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As Trump Seeks to Project Strength, Doctors Disclose Alarming Episodes

In addition to the steroids, Mr. Trump has received an experimental antibody cocktail and is in the midst of a five-day course of remdesivir, an antiviral drug. The White House has a medical unit capable of responding to a president’s health troubles but not with the sophisticated equipment available at Walter Reed.

Mr. Trump, who historically hates hospitals and anything related to illness, has been hankering to get released, according to two people close to him, and some aides expressed fear that he would pressure Dr. Conley into releasing him by claiming to feel better than he actually does. But advisers were also troubled by the doctors’ prediction that they might release him on Monday because if they do not, it would signal that the president is not doing as well as indicated. They also worried that a premature return could lead to a second trip to the hospital if his condition worsens.

Mr. Trump was said to be working from his hospital suite, including receiving a briefing via secure video conference from Robert C. O’Brien, his national security adviser, as well as Secretary of State Mike Pompeo and Gen. Mark A. Milley, the chairman of the Joint Chiefs of Staff.

The president has also been watching lots of television, even more than usual, and has been exasperated by coverage of Saturday’s calamitous handling of his medical information by Dr. Conley and Mr. Meadows, as well as speculation about him transferring powers to Vice President Mike Pence.

He was also angry that no one was on television defending him, as he often is when he cannot inject his own views into news media coverage, aides said. As a result, Rudolph W. Giuliani, his personal lawyer, was expected to appear on several television shows, as was Corey Lewandowski, who was Mr. Trump’s first campaign manager in the 2016 race.

The president was not the only one angry over the weekend. So were many people who work for him at the White House, frustrated at how little information they had received about the health concerns in their workplace. In addition to Mr. Trump, a number of others who work or visit the building regularly have tested positive, including Melania Trump; Hope Hicks, a senior adviser to the president; Nicholas Luna, the director of Oval Office operations; Bill Stepien, the campaign manager; Ronna McDaniel, the chairwoman of the Republican National Committee; and Kellyanne Conway, the president’s former counselor.

Two members of the White House residence staff tested positive for the virus a few weeks ago, two people briefed on their cases said, although they were said not to come in close contact with the president or the first lady. Nonetheless, the presence of the virus in the first couple’s personal quarters once again raised questions not just about what they have been exposed to, but whom they have made vulnerable with lax mask policies around the White House.

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India seeks up to 500 million coronavirus vaccine doses by July

NEW DELHI (Reuters) – India hopes to receive up to 500 million doses of coronavirus vaccine by July to inoculate about 250 million people, health minister Harsh Vardhan said on Sunday, as infections in the world’s second-worst affected country continue to surge.

India’s has recorded some 6.55 million infections, with 75,829 in the past 24 hours, while COVID-19-related deaths have totalled 101,782, health ministry data showed.

“There is a high-level expert body going into all aspects of vaccines,” Vardhan wrote on Twitter. “Our rough estimate and the target would be to receive and utilise 400 to 500 million doses covering (200 million-250 million) people by July 2021.”

Serum Institute of India and private companies have been teaming up with organizations from the Bill & Melinda Gates Foundation to U.S. drug developer Novavax Inc in a scramble to secure vaccines for the country of 1.3 billion people.

India has set up committees to look into various aspects of the vaccine supply chain, including availability timelines for various vaccines, while obtaining commitments from manufacturers to ensure the maximum doses are available, Vardhan said.

He said the federal government is committed to taking all measures to ensure “fair and equitable” distribution of vaccines once they are ready.

The South Asian nation, second only to the United States in caseload, has scope for higher infections as a large chunk of the population remains unexposed to the virus, a survey showed on Tuesday.

To prioritise the distribution of coronavirus vaccines, the health ministry aims to prepare a list of key personnel, such as frontline health workers, by the end of the month.

(Reporting by Nidhi Verma; Editing by William Mallard)

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